Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the Vanguard PS Open Box Porous Femoral (Implants and Instrumentation) - A Consecutive Series Study
- Conditions
- bewegingsapparaatarthroplastyosteoarthritisprostheses
- Registration Number
- NL-OMON56781
- Lead Sponsor
- Amsterdam UMC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
This study is focused on patients treated with the Vanguard PS Open Box Porous
Femoral between 2009 and 2013 within the Amsterdam UMC, location AMC.
The Vanguard PS Open Box Porous Femoral prosthesis is indicated for patients
treated for:
• Painful and disabled knee joint resulting from osteoarthritis, rheumatoid
arthritis, traumatic arthritis where one or more compartments are involved.
• Correction of varus, valgus, or posttraumatic deformity.
• Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of
previous joint replacement procedure.
Additionally, in order to be eligible to participate in this study, a subject
must meet the following criteria:
• The participant must be able to understand the Dutch language in order to
complete the questionnaires.
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
• Off label use.
Absolute contraindications include:
• Infection.
• Sepsis.
• Osteomyelitis.
Relative contraindications include:
• An uncooperative patient or a patient with neurologic disorders who is
incapable of following directions.
• Osteoporosis.
• Metabolic disorders which may impair bone formation.
• Osteomalacia.
• Distant foci of infections which may spread to the implant site.
• Rapid joint destruction, marked bone loss or bone resorption apparent on
roentgenogram.
• Vascular insufficiency, muscular atrophy, neuromuscular disease, and/or
incomplete or deficient soft tissue surrounding the knee.
Subgroup exclusion criteria:
• For the subgroup analysis to determine variability in methodological error,
bilateral patients are excluded from the subgroup since they will already be
exposed to an additional scan.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Assessment of safety by recording and analyzing the incidence and frequency of<br /><br>revisions, complications and adverse events. Relation of the events to implant,<br /><br>instrumentation and/or procedure should be specified.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Performance and clinical benefits demonstrated by PROMs (patient-reported<br /><br>out-come measures).<br /><br><br /><br>Radiographic Outcomes from conventional X-rays and evaluation of induced micro<br /><br>motion using CT-scans and valgus-varus loading of the knee joint.</p><br>